Rabeprazole sodium

Product NDC: 63187-555
11-digit product format: 631870555
Labeler code: 63187
Product ID: 63187-555_45879472-a15c-4577-8df5-a2fbd9c5173d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA202376
Marketing category: ANDA
Marketing start: 2013-11-08
Substance: RABEPRAZOLE SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202376-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-11-08

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A202376-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202376-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202376-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202376-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202376-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202376-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202376-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202376-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202376-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202376-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202376-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202376-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202376-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202376-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202376-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202376-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202376-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202376-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202376-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202376-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202376-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202376-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202376-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202376-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202376-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202376-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202376-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202376-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202376-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202376-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202376-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202376-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202376-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202376-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202376-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202376-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202376-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202376-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202376-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202376-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202376-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rabeprazole sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RABEPRAZOLE SODIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3L36P16U4R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854868	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d1444508-fe40-4f68-8350-52f13399e38a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63187-555-30	Rabeprazole sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3
63187-555-60	Rabeprazole sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	3
63187-555-90	Rabeprazole sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63187-555-30	EA - Each	63187-555	18e51bc0-d356-4f53-8ad0-08051ac8c556	1	2016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RABEPRAZOLE SODIUM	ACTIVE INGREDIENT	3L36P16U4R	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
RABEPRAZOLE	ACTIVE MOIETY	32828355LL	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
DIETHYL PHTHALATE	INACTIVE INGREDIENT	UF064M00AF	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)	INACTIVE INGREDIENT	G4U024CQK6	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
MAGNESIUM OXIDE	INACTIVE INGREDIENT	3A3U0GI71G	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-555	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 3 package rows	20210113_d1444508-fe40-4f68-8350-52f13399e38a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole sodium	RABEPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	04e88b86-e1dd-4c56-8359-45fbcc161f7d	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376
Rabeprazole sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	1855ccab-c377-4962-9225-3c5adc62e2bd	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376
Rabeprazole sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	d1444508-fe40-4f68-8350-52f13399e38a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376 ndc (product): 63187-555

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3L36P16U4R	RABEPRAZOLE SODIUM	117976-90-6	RABEPRAZOLE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854868	RABEprazole sodium 20 MG Delayed Release Oral Tablet	PSN	d1444508-fe40-4f68-8350-52f13399e38a	3
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	d1444508-fe40-4f68-8350-52f13399e38a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-555-30	63187055530	30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-30)	2018-12-01	0000-00-00	No	No	Current
63187-555-60	63187055560	60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-60)	2018-12-01	0000-00-00	No	No	Current
63187-555-90	63187055590	90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-555-90)	2018-12-01	0000-00-00	No	No	Current